China’s Bio-Thera Solutions has received approval from the country’s NMPA to launch a Phase I clinical study comparing the pharmacokinetics and safety of its proposed ustekinumab biosimilar to Johnson & Johnson’s blockbuster psoriasis drug Stelara, the latest in a string of the biotech company’s products to advance into clinical development.

A regulatory framework that encourages physicians to conduct experimental cell and gene therapies have propelled China to become a major developer of such promising cancer-treating tools, but insiders say three are a plethora issues at stake.